Important New Guidance from the FDA
- FDA Draft Guidance Document: Acute Radiation Syndrome - Developing Drugs for Prevention and Treatment. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.
Registration is Now Open for the NIAID-Sponsored Advanced Technologies in Radiation Research (ATRR) Workshop
You are cordially invited to participate in the Advanced Technologies in Radiation Research (ATRR) Workshop, sponsored by the NIAID Radiation and Nuclear Countermeasures Program (RNCP); the Radiation Research Program (RRP), National Cancer Institute (NCI); the National Aeronautics and Space Administration (NASA); and the Radiation Injury Treatment Network (RITN).
The meeting will be held August 17th, 2023 (8:00 am - 4:55 pm EDT) and August 18th, 2023 (8:30 am - 3:30 pm EDT) at the NIAID Conference Center (5601 Fishers Lane, Rockville, MD 20852) for in-person attendees and via Zoom for remote participants.
The ATRR Workshop will be offered as a hybrid meeting, with invited speakers, moderators, and expert panelists attending in person. Due to space limitations, other in-person attendees are limited and will be accepted on a first-come, first-served basis. If you wish to attend in person, please sign up as soon as possible, and indicate this preference when you register using the link below. All other attendees will attend the meeting virtually via the Zoom platform and should select the “virtually” option from the pulldown menu during registration.
CLICK HERE TO REGISTER
All registered attendees will receive an email confirmation with a personalized Zoom link to access the meeting - please do not share this unique Zoom access link with others. If you know of colleagues who would like to participate, please share the above registration link with them.
Helpful NIH Information
- Updates to Funding Opportunity Terminology (NOT-OD-23-109) NIH. The purpose of this notice is to notify the extramural community that NIH is transitioning to updated terminology regarding funding opportunities to better align with the Uniform Administrative Requirements as outlined in 2 CFR Part 200. Effective immediately, NIH will use the term notice of funding opportunity (NOFO) to refer to formal announcements of the availability of Federal funding through a financial assistance program. Previously, such announcements were referred to as funding opportunity announcements (FOAs). See the NIH Grants & Funding Glossary for the full definition. NIH is currently updating websites, documents, and other resources to reflect the new terminology.
- Navigating the NIH. NIH has a vested interest in receiving proposals from a wide range of investigators, from a wide range of applicant institutions. However, data on funding of research project grants (RPGs) and a recent analysis done by CSR on applicant institutions for National Research Service Award (NRSA) fellowship applications indicate some disparities among institutions in terms of funding and application rates.
· A Rule Change for Preliminary Data as Post-Submission Materials. NIH will allow applicants to submit preliminary data as post-submission materials for new applications (Type 1) if the notice of funding opportunity uses the R01, R03, or R21 activity codes and allows preliminary data.
· Address Just-in-Time Requests and Bars to Award Quickly. While most of the just-in-time information we request is routine, be aware that certain codes and comments in your summary statement can indicate a funding restriction or bar to award.
- International Preparedness and Response to Emergencies and Disasters (IPRED). January 14-17, 2024. IPRED is an international conference held in Israel that brings together people who deal with emergencies and disasters worldwide, enriching each other with everything new on the subject. Alongside the lectures and discussions over two days, there is a huge exhibition with all the innovations dealing with emergencies and disasters. An extensive exercise will reveal the innovations and practices related to disasters and emergencies on the conference’s third day. IPRED welcomes abstracts from scientists, health experts, humanitarian workers, search and rescue experts, and researchers in all sectors, including academia, government, civil society, and the private sectors. Submit abstracts for presentation at the conference here (deadline May 31, 2023).
- REAC/TS Advanced Radiation Medicine Course. Save-The-Date! June 26-28, 2023, Oak Ridge, TN. The Advanced Radiation Medicine course, offered by the REAC/TS as part of the Oak Ridge Institute for Science and Education, is designed to educate medical practitioners about advanced radiation medicine diagnosis and treatment as well as current research. This course, designed for healthcare providers, is academically more rigorous than the Radiation Emergency Medicine course. It is primarily an instructive course with some hands-on activities. Group problem-solving is used during the course to highlight the management of complex cases. Recent completion of the Radiation Emergency Medicine course is strongly recommended. Registration coming soon here.
- NASA’s Spaceflight Technology, Applications, and Research (STAR) Program. September 2023 – February 2024. Learn to Design Biology Experiments for Space with STAR, a virtual program for space biosciences training. The annual course targets principal investigators (PIs), senior research scientists, and postdoctoral scholars and aims to facilitate their entry to space biology and preparation for conducting spaceflight experiments using NASA and commercial platforms. Course curriculum includes fundamental space biology and its practical applications, including technical and logistical considerations, opportunities, and the unique advantages and limitations of conducting an experiment in space. Course participants also have opportunities to interact with PIs with prior mission experience, developers of spaceflight technology and flight providers. The solicitation for the 4th annual STAR course is now open on NSPIRES. The deadline to apply is June 2nd, 2023.
- NATO CBRN Medical Training Panel Medical Symposium 2023. June 28-30, 2023, Oak Ridge, TN. The NATO CBRN Medical Training Panel has teamed up with Oak Ridge Institute for Science & Education and the Radiation Emergency Assistance Centre/Training Site, to host the Inaugural NATO Chemical, Biological, Radiological & Nuclear Medical Symposium. This environment will bring world leading speakers, subject matter experts and industry together to learn in a collaborative environment. Registration information available here.
- Junior Biodosimetrist - United Kingdom Health Security Agency, Chilton, Oxfordshire. The Cytogenetics Group is one of the five research groups in the Radiation Effects Department of the Radiation, Chemical and Environmental Hazards Directorate (RCE). The Radiation Effects Department carries out research and delivers advice on the biological effects of radiation and selected chemical agents, and on appropriate response to incidents. The Cytogenetics Group carries out research into biomarkers to quantify ionising radiation exposures. The group also provides a biological dosimetry service unique in the UK. This position is for a skilled, and motivated individual without necessarily requiring previous laboratory skills or experience but having a strong interest in biological sciences. The postholder will provide support to senior scientists whilst developing their own skills and experience to become an independent scientist. The successful candidate will support and contribute towards existing and future research projects across several topics related to biological dosimetry, as well as supporting routine operations in accordance with standard operating procedures.
- Higher Radiation Protection Scientist (Statistician) - United Kingdom Health Security Agency, Chilton, Oxfordshire. The Cytogenetics Group is one of the five research groups in the Radiation Effects Department of the Radiation, Chemical and Environmental Hazards Directorate (RCED). The Radiation Effects Department carries out research and delivers advice on the biological effects of radiation and selected chemical agents, and on appropriate response to incidents. The Cytogenetics Group carries out research into biomarkers to quantify ionising radiation exposures. The group also provides a biological dosimetry service unique in the UK. This position is for a skilled, and motivated individual without necessarily requiring previous experience of statistical analysis of scientific data, or an individual with a biological or related background with a strong interest in statistical analysis and/or developing these skills. The postholder will provide support to senior scientists as well as the group and department to support statistical analysis of data and commercial activities. The successful candidate will support and contribute towards existing and future research projects across several topics related to biological dosimetry.